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The Role of Walnut Consumption on Sleep Quality

NCT ID: NCT04799821

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-03-31

Brief Summary

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Walnuts have a unique nutritional profile, including the sleep-regulating hormone melatonin, tryptophan, and omega-3 fatty acids, the two latest nutrients involved in melatonin and serotonin synthesis. Although it has been claimed that walnuts may improve sleep, to the investigators' knowledge, no studies have been conducted to objectively determine the impact of walnut consumption on sleep and overall well-being. Therefore, this study aims to investigate the effect of daily walnut consumption on sleep parameters (such as quality and duration). Secondarily, it aims to investigate the impact of daily walnut consumption on body composition, eating behavior, and well-being.

Detailed Description

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The study to investigate the effect of daily walnut consumption on sleep quality will be conducted in an 18-week randomized crossover trial, in which participants will be initially assigned to intervention or control conditions for 8-weeks. After 2 weeks of washout, subjects will be crossed over to the alternate intervention and will continue for another 8 weeks. Note that throughout the whole study, each participant will attend 5 visits: 1 initial visit (baseline) and 2 visits in each one of the study conditions (intervention and control).

Conditions

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Healthy Diet Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

Daily walnut consumption

Group Type EXPERIMENTAL

Walnut intake

Intervention Type OTHER

Participants will be asked to consume walnuts along with an isocaloric meal plan that complies with the recommendations of a healthy Mediterranean-style eating pattern.

Control

No walnut consumption

Group Type OTHER

Control

Intervention Type OTHER

Participants will be asked to refrain from walnut intake and to follow an isocaloric meal plan that complies with the recommendations of a healthy Mediterranean-style eating pattern.

Interventions

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Control

Participants will be asked to refrain from walnut intake and to follow an isocaloric meal plan that complies with the recommendations of a healthy Mediterranean-style eating pattern.

Intervention Type OTHER

Walnut intake

Participants will be asked to consume walnuts along with an isocaloric meal plan that complies with the recommendations of a healthy Mediterranean-style eating pattern.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* BMI 19-26 kg/m\^2
* Habitual moderate exercise level
* No recent history of weight change exceeding 2.3kg (5lb) within the prior 3 months.

Exclusion Criteria

* Nuts allergy
* Any acute or chronic diseases
* Smokers
* Any drugs or supplementations
* Any alimentary restrictions or specific diets
* Being a shift or night workers
* Being unable to give written informed consent.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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California Walnut Commission

OTHER

Sponsor Role collaborator

University of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Dra. Maria Izquierdo-Pulido

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Izquierdo-Pulido, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Barcelona

Locations

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Torribera Campus, University of Barcelona

Santa Coloma de Gramenet, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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600269

Identifier Type: -

Identifier Source: org_study_id